Senior Principal Biostatistician, Rare Disease (Open to remote)
EMD Serono

Job Info

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A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

More Info -https://www.emdgroup.com/careers/us/Disclosure-Notice-COVID-Vaccination-Policy-State-Restrictions.pdf

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

The Senior Principal Biostatistician will provide statistical input, write statistical analysis plans and perform statistical analyses for statistically routine protocol development and for safety and efficacy summaries for regulatory submissions. Participate in departmental standardization efforts and provide support towards statistical research in rare disease.

• As Senior Principal: Act as Sr Statistical SME at Global or Regional Program Team level with supervision on normal project with focused scope (Clinical/Safety, Regulatory):
  • Able to integrate regional and global development needs
  • Handle routine studies without supervision and demonstrating ability to bring innovation
  • Drive statistical input for concept sheet (e.g., study design; sample size estimation for the most efficient and practical design; patient randomization) and ensure oversight of CRO for its execution (i.e., protocol/CRF development, integrated analysis plan approval, quality oversight of deliveries,...) without supervision for standard studies.
  • Write comprehensive statistical methods sections for the clinical study report; critically review and co-author these reports ensuring the accuracy of the statistical interpretation.
• For integrated safety and efficacy summaries for regulatory submissions, without direction, write statistical analysis plans and perform statistical analyses (Senior Principal)
• Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation
• With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context
• Understand and follow all Global Biostatistics WIs/SOP and relevant Standards as well as any other relevant WIs/SOPs. Contribute to the development of data and reporting standards
• Contribute to process improvement according to lean concepts and to data and reporting standards improvement (Sr Principal)
• With supervision, support business development activities: Assess current available data in light of literature, Provide statistical expertise, with scenarios, in terms of compound development to registration

Who You Are:

Minimum Qualifications :

• Ph.D. or MS in Statistics, Biostatistics or related discipline
• 6-8 years' experience in the Pharmaceutical/Biotechnology industry in clinical development
• Comfortable in Business English

Preferred Qualifications:

• At least three years' experience in SAS or R programming
• Understanding of ICH/GCP; Able to retrieve and understand other relevant regulations
• Experience in the Pharmaceutical/Biotechnology industry in clinical development
• SAS and R practical and effective knowledge
• Ability to develop an understanding of relevant clinical therapeutic areas
• Exhibit routine and complex problem solving skills
• Able to learn and apply state-of-the-art statistical methodology

This role can be remote based in the US.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits -https://www.emdgroup.com/en/careers/benefits.html

Curious? Apply and find more information athttps://jobs.vibrantm.com

If you are a resident of a Connecticut, Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 250074

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.